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Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People

NCT05251480 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-07-03

No results posted yet for this study

Summary

The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern Ontario Communities. First Nations people with active diabetic foot (DFU) ulcer attending a wound care clinic located at the Rainy River district office. An interventional, two-arm, randomized, prospective study of (1) standard of care (control) vs. (2) DermGEN™ - a decellularized dermal matrix (treatment) will be used in the treatment and management of DFU. Patients will be randomized to each arm (n=60 per arm) based on power calculations using data from our Pilot study.

Conditions

  • Diabetes Mellitus
  • Ulcer Foot
  • Ulcer Healing
  • Diabetic Foot Ulcer
  • Non-healing Wound
  • Wound of Skin
  • Wound; Foot
  • Tissue Injury

Interventions

PROCEDURE

Standard of Care

debridement, wound dressings, offloading

OTHER

DermGEN™

Decellularized human dermal matrix created from donated human skin

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Dalhousie University

    collaborator OTHER

  • Lakehead University

    collaborator OTHER

  • DeCell Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Paul F Gratzer, Ph.D. · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2025-12-30
Completion
2026-12-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251480 on ClinicalTrials.gov